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...prominence from tragedy in St. Louis in 1901. At that time, the standard treatment for children with diphtheria was an antitoxin serum made from the blood of horses. Jim had produced over 30 quarts of antitoxin in three years, but the horse was destroyed after contracting tetanus. The serum from Jim's tainted blood was accidentally bottled and used to treat diphtheria patients, causing the death of 13 children. The serum had been manufactured in local establishments with no central or uniform controls in place to ensure potency and purity. Nor were there inspections or testing of the final product.
Around the time of the St. Louis deaths, a similar tragedy occurred in Camden, N.J. Nine children died from tetanus after receiving contaminated smallpox vaccine.
Recognizing the critical need for regulatory safeguards, Congress passed the Biologics Control Act in 1902. Also known as the "Virus-Toxin Law," the act gave the government the first control over the processes used to make biological products, or biologics, and the responsibility to ensure their safety for the American public.
Biologics include medical products made from living sources, such as humans, animals, plants, and microorganisms. Today, the FDA's Center for Biologics Evaluation and Research (CBER) regulates biologics, such as vaccines, blood and blood components, allergenic patch tests and extracts, human immunodeficiency virus (HIV) and hepatitis tests, gene therapy products, cells and tissues for transplantation, and new treatments for cancers and other serious diseases. The CBER works to ensure the safety, purity, potency, and effectiveness of these products, helping to get treatments on the market for known diseases and to protect against threats of emerging infectious diseases and bioterrorism.
From the Hygienic Laboratory to the CBER
Under the 1902 Biologics Control Act, the CBER's predecessor, the Hygienic Laboratory of the Public Health and Marine Hospital Service, issued regulations mandating that producers be licensed annually for the manufacture and sale of vaccines, serum, and antitoxins. Manufacturing facilities also were required to undergo inspections, and licenses could be revoked or suspended in cases of violations. Labels were required to clearly show the product name and expiration date, and a qualified scientist had to supervise production.
In the several decades after the passage of the 1902 act, the Hygienic Laboratory issued licenses to pharmaceutical firms to make smallpox and rabies vaccines, diphtheria and tetanus antitoxins, and various serums to protect against bacterial infections such as scarlet fever.
In 1906, Congress passed the Pure Food and Drugs Act, which outlawed foods and drugs that were mixed with inferior or impure ingredients (adulterated), or that bore false or misleading claims. But the law made no reference to biological products. Under another law passed in 1938, the Federal Food, Drug, and Cosmetic Act (FD&C Act), a biological product was considered to be a drug. Although parts of the 1938 act were applied to biologics, the act did not modify or supersede the provisions of the 1902 Biologics Control Act. After 1938, the appropriate provisions of the 1902 and 1938 acts...
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